在跨导管大动脉更换过程中脑栓塞碎片的预测因素:SafePass 2首次在人体上进行的研究

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Published on: June 3, 2018

Daniel Grubman¹, Yousif Ahmad², Jonathon A Leipsic³

¹Division of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut; Yale Cardiovascular Research Group, Yale School of Medicine, New Haven, Connecticut.

The American journal of cardiology

|September 18, 2023

概括

在跨导管大动脉置换 (TAVR) 过程中,Emboliner装置安全地捕获了碎片,显示出比预期的更多的栓塞. 心房动,较高的TASK分数和自我扩张的门增加了栓塞负担.

科学领域:

心血管医学心血管医学
干预心脏病学干预心脏病学
生物材料科学生物材料科学

背景情况:

过导管大动脉置换 (TAVR) 程序可以产生显著的栓塞碎片,构成脑血管事件的风险.
目前在TAVR期间减轻脑栓塞的策略有限,需要新的保护装置.

研究的目的:

在TAVR期间评估新型Emboliner栓塞保护导管的安全性和可行性.
在TAVR程序中捕获的栓塞碎片的分布和本病理的特征.

主要方法:

一项前性,非随机,单臂研究 (SafePass 2) 涉及31名接受TAVR的受试者.
评估30天主要不良心脏和脑血管事件 (MACCE) 和技术性能.
计算机断层扫描血管造影的分析和从Emboliner过器中捕获的栓塞残渣的体病学检查.

主要成果:

对于Emboliner设备的100%技术成功率,与设备无关的30天MACCE率为6.5%,与设备无关.
所有过器都捕获了碎片,中位数为191.0颗颗粒>150微米和14.0颗颗粒>500微米.
组织病理学显示主要是急性血栓和/动脉组织;心房动,较高的TASK分数,和与增加的栓塞负荷相关的自我扩张.

结论:

在TAVR期间使用的Emboliner栓塞保护导管是安全的和可行的.
TAVR程序产生了大量的栓塞颗粒,超过了以前的文档.
确定选择性栓塞保护的高风险患者需要进一步的大规模调查.

关键词:

大脑栓塞的发生.血栓保护血栓保护血栓保护主要不良心脏和脑血管事件通过导管进行大动脉替换.

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